Device with therapeutic features

ABSTRACT

Disclosed is a therapeutic stretching apparatus, which in particular provides a user with a system for providing an assist to increase knee extension as well as for maintaining stability of the knee after surgery. This device can not only act as a therapeutic stretching apparatus but also can act as a primary post-op knee brace with locks/limits on hinge to prevent user from further injuring the joint.

BACKGROUND

Technical Field

The present invention related to the field of therapeutic treatment ofjoints, such as needed after surgery.

Description of Related Art

Prior art therapeutic devices are well known in the art. An example isof the inventors own concepts such as shown in U.S. Pat. Nos. 6,669,660,6,872,186, 7,479,121, 7,547,289 and others. However, improvements arealways welcomed.

BRIEF SUMMARY OF VARIOUS EMBODIMENTS OF THE INVENTION

According to various embodiments of the present invention, a therapeuticdevice is provided for use on a length of a user's leg, the lengthincluding an upper leg portion, a lower leg portion, and a kneeintermediate the two, the leg length also defining opposing proximal anddistal sides each extending the length of the leg length, the devicecomprising: a proximal framework portion configured for attachmentrelative to the upper leg portion, the proximal framework portionincluding a leg facing portion configured to be directed towards andgenerally facing the proximal side of the upper leg; a distal frameworkportion configured for attachment relative to the lower leg portion, theproximal framework portion including a leg facing portion configured tobe directed towards and generally facing the proximal side of the upperleg; at least one pivoting connection intermediate and connecting theproximal and distal framework portions, the pivoting connectionconfigured to facilitate pivoting of the proximal and distal frameworkportions in device flexion such as when the device is attached to theleg and leg is in flexion and the proximal and distal framework portionscan pivot relative to each other; a connector configured to selectivelyconnect the proximal and distal framework portions so as to selectivelydiscourage device flexion of the proximal and distal framework upperframe member relative to the lower frame member; and at least oneselectively inflatable bladder between the proximal side of the leg andone of the proximal and distal framework portions, in particular betweenthe proximal side of the leg and the corresponding leg facing portion ofthe one of the proximal and distal framework portions, the elementsabove configured to interact such that inflation of the bladder whilethe connector is connected causes the leg to be urged into extension dueto the pushing of the bladder against the proximal side of the leg.

The device above may include the leg facing portion of the one of theproximal and distal framework portions as a strap configured to beplaced in tension.

The device above may include the connector as an elongate tensileconnector having each end attached to one of the proximal and distalframework portions.

The device above may include the connector including a ratchetcapability configured to take up the length of the elongate tensileconnector.

The device above may include the connector as a one-way ratchetconfiguration proximate the pivoting connection.

The device above may include the framework portion including a strapconfigured for attachment relative to the upper leg.

The device above may include one of the proximal and distal frameworkportions including an elastic strap in contact with the anterior side ofthe leg at approximately the same length at which the bladder is incontact to the proximate side.

The device above may include at least one bladder being a first bladder,and further comprising a second bladder between the proximal side of theleg and the other of the proximal and distal framework portions, inparticular between the proximal side of the leg and the correspondingleg facing portion of the other of the proximal and distal frameworkportions.

The device above may include the other of the proximal and distalframework portions also including an elastic strap in contact with theanterior side of the leg at approximately the same length at which thesecond bladder is in contact to the proximate side.

According to various embodiments of the present invention, a therapeuticdevice is provided for use on a length of a user's leg, the lengthincluding an upper leg portion, a lower leg portion, and a kneeintermediate the two, the leg length also defining opposing proximal anddistal sides each extending the length of the leg length, the devicecomprising: A) a proximal device portion itself comprising: 1) aproximal framework portion configured for attachment relative to theupper leg portion, the proximal framework portion including a leg facingportion configured to be directed towards and generally facing theproximal side of the upper leg; and 2) an inflatable proximal bladderbetween the proximal side of the leg and the proximal framework portion,in particular between the proximal side of the leg and the correspondingleg facing portion of the proximal framework portion; B) a distal deviceportion itself comprising: 1) a distal framework portion configured forattachment relative to the lower leg, the proximal framework portionincluding a leg facing portion configured to be directed towards andgenerally facing the proximal side of the upper leg; and 2) aninflatable distal bladder between the distal side of the leg and thedistal framework portion, in particular between the proximal side of theleg and the corresponding leg facing portion of the distal frameworkportion; C) at least one pivoting connection intermediate and connectingthe proximal and distal device portions, the pivoting connectionconfigured to facilitate pivoting of the proximal and distal deviceportions in device flexion such as when the device is attached to theleg and leg is in flexion and the proximal and distal device portionscan pivot relative to each other; and D) a connector configured toselectively connect the proximal and distal framework portions so as toselectively discourage device flexion of the proximal and distal devicemembers relative to each other, the elements above configured tointeract such that inflation of the proximal and distal bladders whilethe connector is connected causes the leg to be urged into extension dueto the pushing of the bladders against the proximal side of the leg.

The device above may include each leg facing portion of each of the oneof the proximal and distal framework portions being a strap configuredto be placed in tension.

The device above may include the connector as an elongate tensileconnector having each end attached to one of the proximal and distalframework portions.

The device above may include the connector including a ratchetcapability configured to take up the length of the elongate tensileconnector.

The device above may include the connector as a one-way ratchetconfiguration proximate the pivoting connection.

The device above may include the framework portion including a strapconfigured for attachment relative to the upper leg.

The device above may include one of the proximal and distal frameworkportions including an elastic strap in contact with the anterior side ofthe leg at approximately the same length at which the bladder is incontact to the proximate side.

According to various embodiments of the present invention, a method isprovided for providing therapeutic motion to a length of a user's leg,the length including an upper leg portion, a lower leg portion, and aknee intermediate the two, the leg length also defining opposingproximal and distal sides each extending the length of the leg length,the method comprising: A) providing a device which will tend toimmobilize the length of a user's leg so as to discourage extension; B)selectively modifying the device such that the length of a user's legmoves in extension to a first predetermined limit; and C) urging aportion of the length of the user's leg relative to a portion of thedevice via an inflatable bladder pushing against the proximal side ofthe leg, such that the length of the user's leg moves in furtherextension past the first predetermined limit; D) deflating theinflatable bladder such that the length of the user's leg moves inflexion back to approximately the first predetermined limit; and E)again urging the portion of the length of the user's leg relative to aportion of the device via an inflatable bladder such that the length ofthe user's leg moves in further extension past the first predeterminedlimit a second time.

According to various embodiments of the present invention, method isprovided for providing therapeutic motion to a length of a user's leg,the length including an upper leg portion, a lower leg portion, and aknee intermediate the two, the leg length also defining opposingproximal and distal sides each extending the length of the leg length,the method comprising: A) providing a pivoting brace having two parts,and upper part and a lower part, the upper and lower parts beingpivotably connected and configured to move in flexion and extensionalong with the movement of the length of the user's leg in correspondingflexion and extension; B) moving the user's leg in extension to a firstextended position such that the brace moves in extension along with theleg, with the upper part of brace moving in extension relative to thelower part of the brace; C) preventing further extension of the upperpart of brace relative to the lower part of the brace; D) urging aportion of the length of the user's leg relative to a portion of thedevice such that the length of the user's leg moves in further extensionpast the first predetermined limit; D) deflating the inflatable bladdersuch that the length of the user's leg moves in flexion back toapproximately the first predetermined limit; and E) again urging theportion of the length of the user's leg relative to a portion of thedevice via an inflatable bladder such that the length of the user's legmoves in further extension past the first predetermined limit a secondtime.

According to various embodiments of the present invention, method isprovided for providing therapeutic motion to a length of a user'sextremity, the length including an upper extremity portion, a lowerextremity portion, and a joint intermediate the two, the extremitylength also defining opposing proximal and distal sides each extendingthe length of the extremity, the method comprising: A) providing apivoting brace having two parts, and upper part and a lower part, theupper and lower parts being pivotably connected and configured to movein flexion and extension along with the movement of the length of theuser's extremity in corresponding flexion and extension; B) moving theuser's extremity in extension to a first extended position such that thebrace moves in extension along with the extremity, with the upper partof brace moving in extension relative to the lower part of the brace; C)preventing further extension of the upper part of brace relative to thelower part of the brace; D) urging a portion of the length of the user'sextremity relative to a portion of the device such that the length ofthe user's extremity moves in further extension past the firstpredetermined limit; D) deflating the inflatable bladder such that thelength of the user's extremity moves in flexion back to approximatelythe first predetermined limit; and E) again urging the portion of thelength of the user's extremity relative to a portion of the device viaan inflatable bladder such that the length of the user's extremity movesin further extension past the first predetermined limit a second time.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1 is an exemplary drawing showing the overall device according toone embodiment of one of the inventions herein, attached to an exemplaryleg 5. Also numbered are distal air bladder 50 and proximal air bladder40. These two bladders are shown in a relatively deflated configuration.

FIG. 2 is an exemplary drawing similar to FIG. 1, except that theproximal air bladder 40 and the distal air bladder 50 are inflated. Theprevious leg position of FIG. 1 is shown here in dotted line.

FIG. 3A is an illustrative static force diagram generally showingvarious static forces, torques and their directions on the device andthe leg, at a given inflation of the bladders; and FIG. 3B is a tableillustrating calculations and assumptions associated with force andtorque of the device.

FIG. 4 is an illustrative diagram showing portions of the overall device10 (namely the first and second elongate arm assemblies 30 and 40,respectively, and the proximal and distal bridge members 60, 70,respectively. A portion of the leg 5 is also shown in phantom.

FIG. 5 is an illustrative diagram showing the portions of the overalldevice 10 of FIG. 4, but also the four straps of the strap collection.

FIG. 6 is an illustrative diagram showing the portions of the overalldevice 10 of FIG. 5, but also the proximal air bladder 40 and itsinflation bulb 41, the distal air bladder 50 and its inflation bulb 51,and the take up tensile connector.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

Various embodiments of the present invention will now be described morefully hereinafter with reference to the accompanying drawings, in whichsome, but not all embodiments of the invention are shown. Indeed,embodiments of the invention may be embodied in many different forms andshould not be construed as limited to the embodiments set forth herein.Rather, these embodiments are provided so that this disclosure willsatisfy applicable legal requirements. Unless otherwise defined, alltechnical and scientific terms used herein have the same meaning ascommonly known and understood by one of ordinary skill in the art towhich the invention relates. The term “or” is used herein in both thealternative and conjunctive sense, unless otherwise indicated. Likenumbers refer to like elements throughout.

Note that when the term “invention” is used herein, it is notnecessarily used to identify a single isolated concept, but could infact be identifying a plurality of concepts, and should not in any waybe construed as limiting any available coverage afforded any patentissuing from this application to a single concept. Said another way,when the phrase “the invention” is used, it should be understood thatthis could include a multiple set of inventions, each of which could beseparately and independently patented or otherwise protected.

Outline

-   -   Overview    -   Element List    -   General Construction and Operation    -   More Detailed Discussion        -   Overall Device        -   First and Second Elongate Arm Assemblies        -   Proximal and Distal Air Bladders        -   Take-Up Tensile Connector        -   Strap Collection        -   Methods For Use—Therapeutic and Brace Modes        -   Alternate Description of Elements        -   Materials        -   Options and Alternatives    -   Conclusion

OVERVIEW

This invention relates generally to therapeutic stretching apparatus,and in particular provides a user with a system for providing an assistto increase joint extension as well as for maintaining stability of thejoint after surgery. As an example, a system is shown which increasesknee extension as well as for maintaining stability of the knee aftersurgery. This device can not only act as a therapeutic stretchingapparatus but also can act as a primary post-op knee brace withlocks/limits on hinge to prevent user from further injuring the joint.

Other joints should be understood as being capable of manipulation underthe present inventions, including but not limited to the elbow,shoulder, finger joints, ankle, etc.

ELEMENT LIST

-   -   5 Exemplary leg (or portion thereof)    -   10 Overall device        -   20 First elongate arm assembly            -   22 Proximal arm section            -   24 Distal arm section            -   26 Hinge section (aka Hinge 26)        -   30 Second elongate arm assembly            -   32 Proximal arm section            -   34 Lower arm section            -   36 Hinge section (aka Hinge)        -   40 Proximal Air Bladder            -   41 Quick-Release Inflation Bulb        -   50 Distal Air Bladder            -   51 Quick-Release Inflation Bulb        -   60 Proximal bridge member        -   70 Distal bridge member        -   80 Take-up Connector        -   90 Strap Collection            -   92 Proximal anterior outer straps—high tensile strength                fabric            -   93 Proximal anterior inner straps—high tensile strength                fabric plus bladder            -   94 Proximal posterior outer straps—high tensile strength                fabric            -   95 Proximal posterior inner straps—flexible            -   96 Distal anterior inner straps—high tensile strength                fabric plus bladder            -   97 Distal anterior outer straps—high tensile strength                fabric            -   98 Distal posterior inner straps—flexible            -   99 Distal posterior outer straps—high tensile strength                fabric

GENERAL CONSTRUCTION AND OPERATION

This device provides the user with a system for providing an assist toincrease knee extension as well as for maintaining stability of the kneeafter surgery. This device can not only act as a therapeutic stretchingapparatus (while in its “therapeutic mode”) but also be used in a “bracemode”, in which it acts as a primary post-op knee brace withlocks/limits on the hinge to prevent the user from further injuring thejoint.

The general construction includes two elongate arm assemblies 20, 30,each of which extend down opposite sides of the user's leg. Each ofthese assemblies includes a pivot element which is preferably alignedwith the user's knee joint when pivoting. The two assemblies are linkedtogether by “U”-shaped proximal and distal bridge members 60, 70,providing a substantially rigid connection therebetween, while stillallowing the two pivot elements to pivot while in brace mode. Intherapeutic mode, a take up tensile connector connects the two bridgemembers; then the proximal and distal air bladders 40, 50, are inflatedso as to provide a therapeutic action as discussed in later detail.

MORE DETAILED DISCUSSION

Overall Device

The overall device 10 according to one embodiment of the presentinvention is shown in FIGS. 1-6.

The device 10 includes the following subelements:

-   -   First elongate arm assembly 20 (extends down one side of leg)    -   Second elongate arm assembly 30 (extends down other side of leg)    -   Proximal Air Bladder 40 (positioned atop thigh, to move femur)    -   Distal Air Bladder 50 (positioned atop shin, to move tibia)    -   Proximal Bridge Member 60 (spans assemblies 20 and 30)    -   Distal Bridge Member 70 (spans assemblies 20 and 30)    -   Take Up Tensile Connector 80 (connects bridge members 60 and 70)    -   Strap Collection 90 (includes multiple straps)

First and Second Elongate Arm Assemblies 20, 30

The general “framework” of the device (the part providing relativelyrigid structure) consists of two hinged/jointed arm assemblies 20, 30,with locations for the straps to attach.

Each of these arm assemblies 20, 30, is generally similar to the other,except that they are the mirror image of the other, as each fits on oneside of the leg of the user. Although the device 10 may be used witheither leg, it will be assumed for discussion that it is being used onthe left leg. Assuming this to be the case, the first elongate armassembly 20 would be positioned along the left side of the leg 5 asshown in FIG. 4. Similarly, the second elongate arm assembly 30 would bepositioned along the right side of the leg 5.

Each assembly includes a proximal arm section, a distal arm section, anda hinge section intermediate and connecting the two. Proximal armsections are configured to be positioned adjacent to and attachedrelative to the proximal portion of the leg (the portion including thefemur); Distal arm sections are configured to be positioned adjacent toand attached relative to the distal portion of the leg (the portionincluding the tibia). The hinge section is configured to provide a hingefunction, as least in one operational mode of the device 10.

First arm assembly 20 includes a proximal arm section 22, a distal armsection 24, and a hinge section 26 intermediate and connecting theproximal and distal arm sections 22, 24.

Second arm assembly 30 includes a proximal arm section 32, a distal armsection 34, and a hinge section 36 intermediate and connecting theproximal and distal arm sections 32, 34.

The hinge sections 26, 36, (aka “hinges”) are in one inventiveembodiment configured to provide a pivoting connection between theirassociated proximal and distal arm sections. These hinges could have avariety of options. For example they could be configured to have twoselectable modes—a completely locked mode and a completely free mode,the former providing a selectable rigid connection between theassociated proximal and distal arm sections, and the latter providingcomplete pivoting without stops. Another option could also include anadditional “pivot range” mode in which “stops” or “limits” could beprovided that would preclude flexion or extension of the knee outside acertain range of pivot motion. The stop or limits could be adjustable asneeded.

Proximal and Distal Air Bladders 40, 50

During the use of the device 10 in its therapeutic mode, the proximaland distal air bladders 40, 50, are inflated and deflated through theuse of a manual pumping mechanism. This could be done independently, fora personalized application of force to the limb, or at the same time ifthe same bulb is connected to both bladders. In the drawings, proximalair bladder 40 is inflated and deflated via quick release inflation bulb41, and distal air bladder 50 is inflated and deflated via quick releaseinflation bulb 51. As discussed later, proximal air bladder 40 isattached to corresponding proximal anterior inner strap 93, which isitself attached to the frame of the device 10. Similarly, distal airbladder 50 is attached to corresponding distal anterior inner strap 96,which is itself attached to the frame of the device 10.

As the air bladders are inflated during the therapeutic mode of thedevice, the bladders expand between the corresponding straps and the legof the user, causing the leg of the user to be urged along the workingtensile length portions of the straps, thus urging the knee of the leginto extension as shown in FIGS. 1 and 2.

As discussed in later detail, during therapeutic use of the device 10,when the proximal air bladder 40 is inflated and deflated via quickrelease inflation bulb 41, bladder 40 tends to move the femur relativeto the overall framework of the device 10. When the distal air bladder50 is inflated and deflated via quick release inflation bulb 41, bladder50 tends to move the tibia relative to the overall framework of thedevice 10. Due to the positioning of other straps intermediate the legand the framework of the device, such inflation causes the femur andtibia to be moved relative to each other such that the intermediate kneeis urged into greater extension as discussed in later detail.

Proximal and Distal Bridge Members 60, 70

As shown in FIG. 4, the proximal and distal bridge members 60, 70, aresimilar in their “U”-shaped construction, and each span from oneelongate assembly 20 to the other assembly 30, providing a substantiallyrigid connection therebetween.

The proximal bridge member 60 is rigidly attached at one end to theproximal arm section 22 of the first elongate arm assembly 20, andattached at its other end to the proximal arm section 32 of the secondelongate arm assembly 20.

The distal bridge member 70 is rigidly attached at one end to the distalarm section 24 of the first elongate arm assembly 20, and attached atits other end to the distal arm section 34 of the second elongate armassembly 20.

Take-Up Tensile Connector 80

Referring now particularly to FIG. 6, the take-up tensile connector 80is configured to connect the proximal bridge member 60 to the distalbridge member 70 when the device 10 is in its therapeutic mode. One endof the connector 80 attaches to member 70 and the other end attaches tomember 80.

When the connector 80 is in place, it discourages flexion yet allowsextension of the knee, by discouraging “device flexion” and allowing“device extension” of the proximal and distal subassemblies PFP, DFP(aka upper and lower frame subassemblies). “Device flexion” shall beunderstood as the relative movements of the upper and lower framesubassemblies when the leg is in flexion when the device is used as apivoting brace, and “device extension” shall be understood as therelative movements of the upper and lower frame subassemblies when theleg is in extension when the device is used as a pivoting brace.

The connector includes a take-up feature which allows the connector tobe reduced in length while being connected to the proximal bridge member60 and distal bridge member 70. This reduction in length or“contraction” is used to urge the medial portions of the proximal bridgemember 60 and distal bridge member 70 towards each other, causing thebrace to move such that the knee is urged into extension as much aspossible, prior to the use of the balloons as discussed elsewhere.

When the buckle/ratchet and strip are not engaged they will rotate/pivotout of the way so as not to hinder the user from walking around whilethe apparatus is used as a conventional brace.

In one configuration, the take-up tensile connector 80 is in the form ofa buckle/ratchet mechanism and semi-rigid strip; with the buckle/ratchetbeing secured to the proximal bridge member 60 and the strip secured tothe distal bridge member 70. The connector 80 can be in the form of aratchet/buckle having a lever arm on the upper rigid support such thatwhen lifted it moves the strip attached to the lower rigid supporttowards the upper support. When the lever arm is lowered it holds thestrip in its current location. Under one configuration, there is asemi-rigid strip that is rigid enough to be pushed through a slot in theother connector portion, the slot having a ratchet element, such that ifthe brace is pivoted by the user (such as by the user sitting on thefloor and pushing down on the anterior side of it), the ratchet effecttakes place automatically. In this situation, the user could slip thetoothed semi-rigid strip into the ratcheted slot, and then push down onthe brace (against or with the assistance of the leg) so that thetake-up tensile connector is shortened. However, other configurationsperforming similar functions are likewise contemplated.

Strap Collection 90

There are multiple separate straps to secure the brace to the leg;ideally four anterior and four posterior straps. Referring now inparticular to FIG. 5, this “strap collection” 90 includes a plurality ofstraps listed as follows:

Proximal anterior outer straps 92—high tensile strength fabric

Proximal anterior inner straps 93—high tensile strength fabric [attachedto bladder]

Proximal posterior outer straps 94—high tensile strength fabric

Proximal posterior inner straps 95—flexible

Distal anterior inner straps 96—high tensile strength fabric [attachedto bladder]

Distal anterior outer straps 97—high tensile strength fabric

Distal posterior inner straps 98—flexible

Distal posterior outer straps 99—high tensile strength fabric

Note that a single strap could be used for any one of the above“straps”, wound around and turned back as necessary in order to use asingle piece of strapping. “Strap” and “straps” are thus usedinterchangeably (e.g., strap 92 or straps 92). Other flexible materials,in one piece or otherwise, are likely contemplated.

Within the collection 90, the straps for the proximal and distal ends ofthe brace, on both anterior and posterior sides, are in one embodimentof a flexible construction including high tensile strength, (such as afabric like nylon, polypropylene, polyester webbing or the like) andprovide the primary “rigid” (in the tensile direction) attachment of thebrace to the leg. As shown in FIG. 5, these straps are the following:

-   -   Proximal anterior outer straps 92—high tensile strength fabric    -   Proximal posterior outer straps 94—high tensile strength fabric    -   Distal anterior outer straps 97—high tensile strength fabric    -   Distal posterior outer straps 99—high tensile strength fabric

Within the strap collection 90, on the posterior side of the brace,towards the middle of the brace but not on the joint, include elasticstraps (such as webbing with suitable rubber strands or the like in thetensile direction) to allow the knee to move relative to the braceduring therapeutic use of the device 10, while still providing asuitable urging force upon the anterior side of the leg during use as abrace. As shown in FIG. 5, these straps are the following:

-   -   Proximal posterior inner straps 95—flexible    -   Distal posterior inner straps 98—flexible

Within the strap collection 90, anterior middle straps will contain theair bladders and be comprised of the same or other suitable similar hightensile strength fabric material. They attach to and support the airbladders in such a way that allows the bladder to be sandwiched betweenthe fabric strap and the user's leg. These include the following straps:

-   -   Proximal anterior inner straps 93—high tensile strength fabric        [attached to bladder]    -   Distal anterior inner straps 96—high tensile strength fabric        [attached to bladder]

Methods for Use: Therapeutic Mode and Brace Mode

Under one embodiment of one invention disclosed herein, the device 10may be used in two different modes: “therapeutic mode” and “brace mode”.The device may be used in only one of said modes, or may be usedalternately in either mode, with or without removal in between modes.

In therapeutic mode, the device 10 may be used in a particular manner inorder to provide advantageous therapeutic stretching or the like ofcertain aspects of the user's body. In particular, the brace may be usedto provide increased knee extension in a selectively and predeterminedcontrolled environment, such as is often needed after knee surgery orthe like.

In brace mode, the device 10 may be used in order to provide a moretraditional brace function, that being to provide structural assistanceto support the knee or adjacent parts of the leg, provide limits onflexion and/or extension of the leg in order to preclude further injury,and as a post-operative brace support system to protect the leg andprevent unexpected injury during the vulnerable post-operative periodwhen the patient lacks pain control and muscle control.

For either mode, installation and removal of the device to and from theleg is essentially the same. For installation, typically the hinges 26,36 are set to move freely enough to allow the device to be installed.The device 10 is then attached to the intended leg via the variousstraps in the strap collection 90. Each of the four distal straps areattached to the distal part of the leg as shown in the various figures,as are the four proximal straps attached to the proximate part of theleg, such that the two hinges 26, 36 are on either side of the knee,with the hinge axes preferably aligning with the axis of the knee joint.

Should the user then elect to use the device 10 in therapeutic mode, inone embodiment of the invention the user removes any restrictions fromthe hinges, i.e. locks and limits, before beginning the process. Onceall locks/limits are removed/disengaged from the hinges, the user thenextends his/her knee as far as possible, and then engages and retractsthe take-up tensile connector as much as possible without experiencingsignificant pain. In one embodiment, the user is instructed to retractthe take-up tensile connector until the user just begins to feel anextension stretch in the knee.

At this point, the deflated air bladders 40, 50, are then inflated viamanual operation of the corresponding inflation bulbs 41, 51, from forexample the deflated condition of FIG. 1 to the inflated condition ofFIG. 2. As may be seen, the bladders, both being on the anterior side ofthe leg, will begin to press the knee into more extension, providing adesired stretching process. The take up tensile connector 80 will beplaced in ever increasing tension during this inflation process.

Thus it may be understood that when the patient uses the brace tostretch his knee into extension, in one inventive embodiment he mustfirst lock the two rigid anterior proximal and distal bridge memberstogether with a ratchet strap. The ratchet strap is then levered anumber of times to close the gap between the proximal and distal bridgemembers until the patient just begins to feel an extension stretch inthe knee. At this point, the patient uses the bulb and bladder system toperform the final intermittent stretching protocol of inflation anddeflation to cause the final extension stretch of the knee. The formalprotocol can be modified by the patient; one suggestion is a stretchingprogram duration of 10 minutes per session at frequency of 6 sessionsper day.

An exemplary showing of the general forces, torques and their directionson the device 10 and the leg is shown in FIG. 3. As shown in FIG. 3, fora given axis, (e.g., the Y axis) As may be understood, in a given axis,for example, the x axis:T1Py+T1Dy=T2Py+T2Dy

Assuming that all four tensile forces are approximately equal, clockwisetorque exists on the proximal frame portion, and counterclockwise torqueexists on the distal frame portion. Thus there will be positive tensionin the take-up tensile member, having a value of “Tensile Force 3”.

Note that the user can at any time terminate such balloon-inducedstretching by releasing the compressed air within the inflation bulbs41, 51. In one embodiment of one invention, bulbs have “quick-release”buttons are used so as to allow the user to quickly release the pressureshould too much pain be encountered.

After the desired stretch is complete, the air is released from thebladders 40, 50, and the take up tensile connector 80 is disconnected.

The device is then ready to be either removed, or placed in brace mode.Removal is readily accomplished by disengaging the various straps in thestrap collection 90 from the leg.

If it is desired to put the device 10 into brace mode, the take uptensile connector 80 is suitably secured in an out of the way disengagedconfiguration. The hinges 26, 36, are then set as needed to provide thebrace effect as needed. In one embodiment, the hinges could becompletely locked; this might be a good setting immediately followingsurgery. The hinges could then be adjusted as known in the art toprovide a desired range of pivoting motion with finite “stops”precluding flexion or extension of the knee past a certain range.

Alternate Description of Elements

It may be understood that the interconnections of the proximal anddistal bridge members 60 and 70 with the first and second elongate armassemblies 20 and 30 provide in effect two relatively pivoting proximaland distal framework portions, each of which are configured to attach toleg. The proximal framework portion (not labeled in the drawings, butreferenced in this text as “PFP”) include the proximal arm section 22,the proximal arm section 32, the proximal bridge member 60, and theproximal straps 92, 93, 94, and 95. The distal framework portion (notlabeled in the drawings, but referenced in this text as “DFP”) includethe distal arm section 24, the distal arm section 34, the distal bridgemember 70, and the distal straps 96, 97, 98, and 99. These relativelypivoting proximal and distal framework portions PFP and DFP pivot via atleast one pivoting connection, in the drawings shown through theintermediate hinge sections 26, 36, which preferably have substantiallycommon pivot axes (when they are so free to pivot).

These proximal and distal framework portions PFP and DFP could bethought of as being part of larger proximal and distal device portions,with each device portion including a framework portion and a bladder.These proximal and distal device portions likewise pivot via at leastone pivoting connection, in the drawings shown through the sameintermediate hinge sections 26, 36, which preferably have substantiallycommon pivot axes (when they are so free to pivot).

Said another way, the “Proximal Device Portion” (not labeled in thedrawings but referenced in this text as “PDP”) includes the proximalframework portion PFP, and the proximal bladder 40. Similarly, the“Distal Device Portion” (not labeled in the drawings but referenced inthis text as “DDP”) includes the distal framework portion DFP, and thedistal bladder 50. The proximal and distal device portions pivot via thetwo hinge sections 26, 36, when so free to pivot.

The proximal and distal framework portions could also be known as “upperand lower framework portions”, “proximal and distal frame portions”,“upper and lower frame portions”, or other suitable terms.

The proximal and distal device portions PFP and DFP could also be knownas “upper and lower device portions”, or other suitable terms.

Materials

In one embodiment, the frame assemblies 20, 30, could be made of variousmaterials, including aluminum, steel, titanium or other metal alloys,carbon fiber or other fiber enhanced plastic, wood, or other suitablyrigid metals, plastics, or other materials.

In one embodiment, the “high tensile” straps 92, 93, 94, 96, 97, and 99could be made of fabric webbing such as nylon, polypropylene, polyesterwebbing or the like. The more elastic straps 95 and 98 could be made ofelastic straps (such as webbing with suitable rubber strands or the likein the tensile direction).

Options and Alternatives

Note that multiple bladders could be used in place of a single bladdermentioned above, as appropriate. Any inflator device could be used,although in one embodiment a quick release of air feature is desired toallow the user to quickly reduce pressure in case of pain.

Note that both bladders 40, 50, mentioned above could be pumped by samebulb, either at the same time, or individually by allowing the bulb tobe selectively attached to either bladder as needed or by appropriatevalving. Each bladder could be inflated separately/individually ortogether at varying rates and pressures. The bulb system could beincorporated into the structure of the bladder or brace like theintegral air pump in e.g., some Nike® or Reebock® shoes.

While the device is in brace mode, the bladders could be left in placein their deflated state between the leg and the proximate strap, or thebladders could be removed as desired.

The air bladders may be inflated manually by air bulbs; either through atube running from the bag to the bulb or from inserting the bulbdirectly into the bag.

Note that the hinge sections 26, 36, (aka “hinges”) could provide notonly the functions described above (complete locking, completely freepivoting, selected range pivoting), but they could also be additionallyconfigured to include a “ratchet” mode, which would provide a functionsimilar to the ratcheting Take Up Tensile Connector 80 also mentionedabove, which would obviate the need for the connector (the hinge wouldbe put into a ratchet mode that would allow for one-way pivoting of thedevice in the “device extension” direction (prior to use of thebladders).

In the description above, the flexible posterior straps 95 and 98 arestretchable, so as to provide a bias on the posterior side of the leg.It should be understood that such a strap configuration could include afeature to allow for snugging up with a second, parallel, non-stretchingstrap to provide for more structural support during brace mode. Also, anumber of different straps could be used, i.e., each strap could havedifferent material properties with a range from stiff to elastic. Thesystem would be changed by replacing a strap with one more elastic orstiff. Such a strap could also have an elastic segment AND a stiffsegment. The stiff segment could be attached to the front of the staysof the brace and the elastic segment could be attached to the back ofthe stays of the brace. Thus, the thigh or leg could stretch backwardsout of the brace but not forward.

Another variation of straps 95 and 98 could include use of a fully rigidstrap with an elastic portion that spans like a chord across one segmentof the strap. Thus, the elastic portion would initially engage the limb,but the rigid portion would come into play when the elastic strapbottoms out on the rigid strap. Alternately, straps 95 and 98 could bereplaced temporarily by a stiff strap when the device is used solely asa brace.

CONCLUSION

Many modifications and other embodiments of the invention set forthherein will come to mind to one skilled in the art to which thisinvention pertains having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the invention is not to be limited to the specificembodiments disclosed and that modifications and other embodiments areintended to be included within the scope of the appended claims.Although specific terms are employed herein, they are used in a genericand descriptive sense only and not for purposes of limitation.

That which is claimed:
 1. A therapeutic device for use on a length of aleg of a user, said length including an upper leg portion, a lower legportion, and a knee intermediate the upper leg portion and the lower legportion, said leg length also defining opposing medial and lateral sideseach extending the length of said leg length, said device comprising: aproximal framework portion configured for attachment relative to theupper leg portion, said proximal framework portion including a legfacing portion configured to be directed towards and generally facingsaid upper leg portion; one or more proximal framework securing membersoperatively coupled to the proximal framework portion, said proximalframework securing members configured for securing the proximalframework portion to the upper leg portion; a distal framework portionconfigured for attachment relative to the lower leg portion, said distalframework portion including a leg facing portion configured to bedirected towards and generally facing said lower leg portion; at leastone operative connection intermediate to and operatively connecting saidproximal and distal framework portions, said at least one operativeconnection configured to facilitate manipulation of said proximal anddistal framework portions in device flexion when said device is attachedto said leg and when said leg is in flexion; a proximal bridge attachedto the proximal framework at a position between at least one of the oneor more proximal framework securing members and the at least oneoperative connection, wherein said proximal bridge is configured forattachment to the proximal framework at each of the medial and lateralsides of the upper leg portion, said proximal bridge adapted to extendacross and above an anteromedian portion of the upper leg portion,wherein said proximal bridge is configured not to touch or otherwiseattach to said anteromedian portion of said upper leg portion; and anextension assistor directly attached to the proximal bridge and thedistal framework portion, wherein said extension assistor is configuredto selectively discourage device flexion of said proximal and distalframework portions relative to one another, and, when activated, saidextension assistor selectively encourages device extension of saidproximal and distal framework portions relative to one another, therebycausing said leg to be urged into extension.
 2. The therapeutic deviceas claimed in claim 1, wherein the device further comprises: aninflatable proximal bladder adapted to be positioned between an anteriorportion of said upper leg portion and at least one of said one or moreproximal framework securing members; and wherein said inflatableproximal bladder is configured to interact with said upper leg portionand the at least one of said one or more proximal framework securingmembers such that inflation of said inflatable proximal bladder whilesaid extension assistor is connected causes said leg to be urged intoextension due to the pushing of said inflatable proximal bladder againstsaid upper leg portion and the at least one of said one or more proximalframework securing members.
 3. The therapeutic device as claimed inclaim 2, wherein the at least one of said one or more proximal frameworksecuring members comprises an elastic strap adapted to be in contactwith an anterior side of said upper leg portion at approximately a samelength at which said inflatable proximal bladder is in contact to saidupper leg portion.
 4. The therapeutic device as claimed in claim 1,wherein said one or more proximal framework securing members comprisesone or more straps configured to be placed in tension.
 5. Thetherapeutic device as claimed in claim 1, wherein said extensionassistor comprises an elongate tensile connector having an end attachedto said proximal bridge.
 6. The therapeutic device as claimed in claim5, wherein said extension assistor includes a ratchet capabilityconfigured to take up a length of said elongate tensile connector. 7.The therapeutic device as claimed in claim 1, wherein said extensionassistor comprises a one-way ratchet configuration proximate saidoperative connection.
 8. The therapeutic device as claimed in claim 1,wherein the extension assistor comprises a tensile member and a tensiletake-up connector, wherein a first end of the tensile member is directlyattached to the proximal bridge or the distal framework portion and asecond end of the tensile member is directly attached to the tensiletake-up connector, and wherein the tensile take-up connector is directlyattached to the proximal bridge or the distal framework portion.
 9. Atherapeutic device for use on a length of a leg of a user, said lengthincluding an upper leg portion, a lower leg portion, and a kneeintermediate the upper leg portion and the lower leg portion, said leglength also defining opposing medial and lateral sides each extendingthe length of said leg length, said device comprising: a proximalframework portion configured for attachment relative to the upper legportion, said proximal framework portion including a leg facing portionconfigured to be directed towards and generally facing said upper legportion; a distal framework portion configured for attachment relativeto the lower leg portion, said distal framework portion including a legfacing portion configured to be directed towards and generally facingsaid lower leg portion; one or more distal framework securing membersoperatively coupled to the distal framework portion, said distalframework securing members configured for securing the distal frameworkportion to the lower leg portion; at least one operative connectionintermediate to and operatively connecting said proximal and distalframework portions, said at least one operative connection configured tofacilitate manipulation of said proximal and distal framework portionsin device flexion when said device is attached to said leg and when saidleg is in flexion; a distal bridge configured for attachment along thedistal framework at a position between at least one of the one or moredistal framework securing members and the at least one operativeconnection, wherein said distal bridge is configured for attachment tothe distal framework at each of the medial and lateral sides of thelower leg portion, said distal bridge adapted to extend across and abovean anteromedian portion of the lower leg portion, wherein said distalbridge is configured not to touch or otherwise attach to saidanteromedian portion of said lower leg portion; and an extensionassistor directly attached to the distal bridge and the proximalframework portion, wherein said extension assistor is configured toselectively discourage device flexion of said proximal and distalframework portions relative to one another, and, when activated, saidextension assistor selectively encourages device extension of saidproximal and distal framework portions relative to one another, therebycausing said leg to be urged into extension.
 10. The therapeutic deviceas claimed in claim 9, wherein the device further comprises: aninflatable distal bladder adapted to be positioned between an anteriorportion of said lower leg portion and at least one of said one or moredistal framework securing members; and wherein said inflatable distalbladder is configured to interact with said lower leg portion and the atleast one of said one or more distal framework securing members suchthat inflation of said inflatable distal bladder while said extensionassistor is connected causes said leg to be urged into extension due tothe pushing of said inflatable distal bladder against said lower legportion and the at least one of said one or more distal frameworksecuring members.
 11. The therapeutic device as claimed in claim 10,wherein the at least one of said one or more distal framework securingmembers comprises an elastic strap adapted to be in contact with ananterior side of said lower leg portion at approximately a same lengthat which said inflatable distal bladder is in contact to said lower legportion.
 12. The therapeutic device as claimed in claim 9, wherein saidone or more distal framework securing members comprises one or morestraps configured to be placed in tension.
 13. The therapeutic device asclaimed in claim 9, wherein said extension assistor comprises anelongate tensile connector having an end attached to said distal bridge.14. The therapeutic device as claimed in claim 13, wherein saidextension assistor includes a ratchet capability configured to take up alength of said elongate tensile connector.
 15. The therapeutic device asclaimed in claim 9, wherein said extension assistor comprises a one-wayratchet configuration proximate said one or more operative connection.16. The therapeutic device as claimed in claim 9, wherein the extensionassistor comprises a tensile member and a tensile take-up connector,wherein a first end of the tensile member is directly attached to thedistal bridge or the proximal framework portion and a second end of thetensile member is directly attached to the tensile take-up connector,and wherein the tensile take-up connector is directly attached to thedistal bridge or the proximal framework portion.
 17. A therapeuticdevice for use on a length of a leg of a user, said length including anupper leg portion, a lower leg portion, and a knee intermediate theupper leg portion and the lower leg portion, said leg length alsodefining opposing medial and lateral sides each extending the length ofsaid leg length, said device comprising: a proximal framework portionconfigured for attachment relative to the upper leg portion, saidproximal framework portion including a leg facing portion configured tobe directed towards and generally facing said upper leg portion; one ormore proximal framework securing members operatively coupled to theproximal framework portion, said proximal framework securing membersconfigured for securing the proximal framework portion to the upper legportion; a distal framework portion configured for attachment relativeto the lower leg portion, said distal framework portion including a legfacing portion configured to be directed towards and generally facingsaid lower leg portion; one or more distal framework securing membersoperatively coupled to the distal framework portion, said distalframework securing members configured for securing the distal frameworkportion to the lower leg portion; at least one operative connectionintermediate to and operatively connecting said proximal and distalframework portions, said at least one operative connection configured tofacilitate manipulation of said proximal and distal framework portionsin device flexion when said device is attached to said leg and when saidleg is in flexion; a proximal bridge attached to the proximal frameworkat a position between at least one of the one or more proximal frameworksecuring members and the at least one operative connection, wherein saidproximal bridge is configured for attachment to the proximal frameworkat each of the medial and lateral sides of the upper leg portion, saidproximal bridge adapted to extend across and above an anteromedianportion of the upper leg portion, wherein said proximal bridge isconfigured not to touch or otherwise attach to said anteromedian portionof said upper leg portion; a distal bridge attached to the distalframework at a position between at least one of the one or more distalframework securing members and the at least one operative connection,wherein said distal bridge is configured for attachment to the distalframework at each of the medial and lateral sides of the lower legportion, said distal bridge adapted to extend across and above ananteromedian portion of the lower leg portion, wherein said distalbridge is configured not to touch or otherwise attach to saidanteromedian portion of said lower leg portion; and an extensionassistor directly attached to the proximal bridge and the distal bridge,wherein said extension assistor is configured to selectively discouragedevice flexion of said proximal and distal framework portions relativeto one another, and, when activated, said extension assistor selectivelyencourages device extension of said proximal and distal frameworkportions relative to one another, thereby causing said leg to be urgedinto extension.
 18. The therapeutic device as claimed in claim 17,wherein the device further comprises: an inflatable proximal bladderadapted to be positioned between an anterior portion of said upper legportion and at least one of said one or more proximal framework securingmembers; an inflatable distal bladder adapted to be positioned betweenan anterior portion of said lower leg portion and at least one of saidone or more distal framework securing members; and wherein saidinflatable proximal bladder and said inflatable distal bladder areconfigured to interact such that inflation of said inflatable proximaland distal bladders while said extension assistor is connected causessaid leg to be urged into extension due to the pushing of saidinflatable proximal bladder against said upper leg portion and the atleast one of said one or more proximal framework securing members, anddue to the pushing of said inflatable distal bladder against said lowerleg portion and the at least one of said one or more distal frameworksecuring members.
 19. The therapeutic device as claimed in claim 18,wherein the at least one of said one or more proximal framework securingportions or said one or more distal framework securing portionscomprises one or more includes an elastic straps adapted to be incontact with (i) an anterior side of said upper leg portion atapproximately a same length at which said inflatable proximal bladder isin contact to said upper leg portion or (ii) an anterior side of saidlower leg portion at approximately a same length at which saidinflatable distal bladder is in contact to said lower leg portion. 20.The therapeutic device as claimed in claim 17, wherein said one or moreproximal framework securing members or said one or more distal frameworksecuring members comprises one or more straps configured to be placed intension.
 21. The therapeutic device as claimed in claim 17, wherein saidextension assistor comprises an elongate tensile connector having afirst end attached to one of said proximal bridge or said distal bridge.22. The therapeutic device as claimed in claim 21, wherein saidextension assistor includes a ratchet capability configured to take up alength of said elongate tensile connector.
 23. The therapeutic device asclaimed in claim 17, wherein said extension assistor comprises a one-wayratchet configuration proximate said at least one operative connection.24. The therapeutic device as claimed in claim 17, wherein the extensionassistor comprises a tensile member and a tensile take-up connector,wherein a first end of the tensile member is directly attached to theproximal bridge or the distal bridge and a second end of the tensilemember is directly attached to the tensile take-up connector, andwherein the tensile take-up connector is directly attached to theproximal bridge or the distal bridge.